The RUTI trial: a feasibility study exploring Chinese herbal medicine for the treatment of Recurrent Urinary Tract Infections
The RUTI trial: a feasibility study exploring Chinese herbal medicine for the treatment of Recurrent Urinary Tract Infections
Ethnopharmacological relevance
Chinese herbal medicine (CHM) is a widely used traditional intervention that may have a role to play in addressing the global problem of antimicrobial resistance in conditions such as recurrent urinary tract infections (RUTIs).
Aim of the study
To evaluate the feasibility of administering standardised and individualised formulations of CHM for RUTIs as a Clinical Trial of an Investigational Medicinal Product (CTIMP) within primary care of the UKs National Health Service (NHS).
Materials and methods
Regulatory approval was applied for a placebo controlled, double blinded randomised controlled feasibility trial comparing a) standardised CHM vs placebo administered via General practitioners, and b) individualised CHM vs placebo administered by an experienced CHM practitioner. Primary feasibility outcomes included: gaining regulatory approval, recruitment, randomisation, retention, safety and the relevance of outcomes measures.
Results
Regulatory approval for testing CHM as a CTIMP was successfully obtained. Recruitment to the trial was slow and non-NHS self-help networks were required to find participants for the individualised arm (n=31). Retention and data collection in the standardised arm (n= 30) were problematic, but these were acceptable in the individualised arm. The use of a daily symptom diary was not a suitable outcome measure for women with continuous infection. Other measures showed promising preliminary data for the individualised arm on improvement in symptoms, and reduction in antibiotic use during and after the trial.
Conclusion
CHM can fulfil the demanding requirements of a CTIMP study but it may not be feasible at this point in time to recruit and treat via NHS primary care. However acceptable rates of recruitment and retention via self-help groups and promising preliminary results in the individualised arm suggest it would be worth testing this approach in a full trial.
Antimicrobial, Traditional Chinese Medicine, clinical trial
1-13
Flower, Andrew
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Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Harman, Kim
f2744e31-7c87-4fc5-baa2-fd75ff678522
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
28 October 2019
Flower, Andrew
6cbf5d07-c3ed-4d3a-a474-9c8b19a97a9c
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Harman, Kim
f2744e31-7c87-4fc5-baa2-fd75ff678522
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Flower, Andrew, Willcox, Merlin, Harman, Kim, Stuart, Beth and Moore, Michael
(2019)
The RUTI trial: a feasibility study exploring Chinese herbal medicine for the treatment of Recurrent Urinary Tract Infections.
Journal of Ethnopharmacology, 243, , [111935].
(doi:10.1016/j.jep.2019.111935).
Abstract
Ethnopharmacological relevance
Chinese herbal medicine (CHM) is a widely used traditional intervention that may have a role to play in addressing the global problem of antimicrobial resistance in conditions such as recurrent urinary tract infections (RUTIs).
Aim of the study
To evaluate the feasibility of administering standardised and individualised formulations of CHM for RUTIs as a Clinical Trial of an Investigational Medicinal Product (CTIMP) within primary care of the UKs National Health Service (NHS).
Materials and methods
Regulatory approval was applied for a placebo controlled, double blinded randomised controlled feasibility trial comparing a) standardised CHM vs placebo administered via General practitioners, and b) individualised CHM vs placebo administered by an experienced CHM practitioner. Primary feasibility outcomes included: gaining regulatory approval, recruitment, randomisation, retention, safety and the relevance of outcomes measures.
Results
Regulatory approval for testing CHM as a CTIMP was successfully obtained. Recruitment to the trial was slow and non-NHS self-help networks were required to find participants for the individualised arm (n=31). Retention and data collection in the standardised arm (n= 30) were problematic, but these were acceptable in the individualised arm. The use of a daily symptom diary was not a suitable outcome measure for women with continuous infection. Other measures showed promising preliminary data for the individualised arm on improvement in symptoms, and reduction in antibiotic use during and after the trial.
Conclusion
CHM can fulfil the demanding requirements of a CTIMP study but it may not be feasible at this point in time to recruit and treat via NHS primary care. However acceptable rates of recruitment and retention via self-help groups and promising preliminary results in the individualised arm suggest it would be worth testing this approach in a full trial.
Text
RUTI trial J Ethnopharmacology Final Accepted
- Accepted Manuscript
More information
Accepted/In Press date: 3 May 2019
e-pub ahead of print date: 10 May 2019
Published date: 28 October 2019
Keywords:
Antimicrobial, Traditional Chinese Medicine, clinical trial
Identifiers
Local EPrints ID: 430884
URI: http://eprints.soton.ac.uk/id/eprint/430884
ISSN: 0378-8741
PURE UUID: 4d4bb52c-23c6-462b-993f-6a12eb2e570d
Catalogue record
Date deposited: 16 May 2019 16:30
Last modified: 16 Mar 2024 07:49
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Contributors
Author:
Andrew Flower
Author:
Kim Harman
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